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RecruitingNot ApplicableNCT07095426

Impact of Supplemental Fiber on Gut and Vascular Health Related in Obesity Phenotypes

Interplay Between Metabolic Risk Factors, Body Mass Index, and the Gut/Vascular Response to Supplemental Fiber

Sponsor

Ball State University

Enrollment

20 participants

Start Date

May 20, 2025

Study Type

INTERVENTIONAL

Conditions

Metabolic SyndromeHealthy ParticipantsMetabolically Healthy ObesityMetabolically Abnormal Obesity

Summary

Based on prior research, the investigators are interested in whether an intervention targeting gut health (supplemental fiber for 9 weeks total) will improve vascular health in individuals with obesity. Additionally, the investigators are interested in if this response differs based on whether individuals with obesity have very few heart disease risk factors or several heart disease risk factors.

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria13

  • Participants are 18-55 years old.
  • Participants BMI is ≥30 kg/m2 - this BMI requirement is due to our research aims.
  • Participants have either 0-1 or 2+ of the following risk factors outside of the normal reference ranges: blood pressure, blood sugar, triglycerides, and HDL-cholesterol.
  • Participants are not pregnant or expecting to become pregnant (females only). •Participants are not postmenopausal (females only).
  • Participants have not been diagnosed with an advanced cardiometabolic condition (e.g., cardiovascular disease, type 2 diabetes).
  • Participants have not been diagnosed with a chronic inflammatory condition (e.g., rheumatoid arthritis, inflammatory bowel disease, diverticulosis/diverticulitis).
  • Participants do not regularly take anti-inflammatory drugs (more than 2x week) and are willing to suspend use of these medications for 3 days leading up to in-lab visits.
  • Participants do not take weight-loss medications (e.g., Ozempic, Wegovy).
  • Participants do not use tobacco products or any illicit drugs.
  • Participants have not used antibiotics or probiotics in the last month.
  • Participants do not have dietary restrictions prohibiting them from consuming the fiber supplement (e.g., food allergies/intolerance).
  • Participants do not have a pacemaker.
  • Participants are able to lie on their back (supine position) in the dark for at least 10 minutes (related to vascular measurements).

Exclusion Criteria12

  • Participants are not 18-55 years old.
  • Participants BMI is not ≥30 kg/m2 - this BMI requirement is due to our research aims.
  • Participants do not have either 0-1 or 2+ of the following risk factors outside of the normal reference ranges: blood pressure, blood sugar, triglycerides, and HDL-cholesterol.
  • Participants are pregnant or expecting to become pregnant (females only).
  • Participants are postmenopausal (females only).
  • Participants have been diagnosed with an advanced cardiometabolic condition (e.g., cardiovascular disease, type 2 diabetes).
  • Participants have been diagnosed with a chronic inflammatory condition (e.g., rheumatoid arthritis, inflammatory bowel disease, diverticulosis/diverticulitis). •Participants regularly take anti-inflammatory drugs (more than 2x week) and are not willing to suspend use of these medications for 3 days leading up to in-lab visits.
  • Participants take weight-loss medications (e.g., Ozempic, Wegovy).
  • Participants use tobacco products or any illicit drugs.
  • Participants have used antibiotics or probiotics in the last month.
  • Participants have dietary restrictions prohibiting them from consuming the fiber supplement (e.g., food allergies/intolerance).
  • Participants have a pacemaker.

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Interventions

DIETARY_SUPPLEMENTinulin

6g inulin from chicory root per day for one week and 12g inulin per day for eight weeks dissolved into cool or room temperature liquid

Locations(1)

Health Professions Building

Muncie, Indiana, United States

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NCT07095426

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